Cerebral NIRS Monitoring During Anesthesia in Neonates and Infants

Cerebral Oxygenation Clinical Trial

Official title:

Monitoring Of REgional Cerebral Oxygenation (rcSO2 ) With Near INFrared SpectrOscopy (NIRS) During Non-cardiac Surgery in Preterms, Neonates and Infants in Addition to Standard Monitoring to Guide Intraoperative Management

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04132414
• Other study ID #: 31-175 ex 18/19
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: December 2023

Study information

• Verified date: July 2022
• Source: Medical University of Graz
• Contact: Stefan Heschl, M.D., Ph.D.
• Phone: +4331638513027
• Email: stefan.heschl[@]medunigraz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The brain is a very vulnerable organ, especially in premature babies, newborns and infants. However, during anesthesia, the oxygenation of the brain can only be monitored indirectly and insufficiently. Near-infrared spectroscopy (NIRS) is an established monitoring method in other areas (e.g., neonatology, cardiac anesthesia), which provides non-invasive information about the regional oxygen supply of the brain. The integration of this monitoring device into the anaesthesiological care for neonates and infants could reduce the risk of cerebral hypoxia. The planned study investigates whether the use of NIRS in anesthetized children up to 6 months can prevent or influence the occurrence of cerebral hypoxia.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• Expected duration of Anesthesia >45 minutes
• Intervention/surgery in the operating room

Exclusion Criteria:

• Impossibility to place cerebral NIRS sensor
• Known cerebral pathology
• Missing parental consent
• Congenial cardiac condition with right to left shunt
• Cardiac surgery

Related Conditions & MeSH terms

• Cerebral Oxygenation

Intervention

Diagnostic Test:
• NIRS open
Treatment according to protocol in phases of cerebral hypoxia.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral hypoxic burden	Time under 65% cerebral oxygen saturation	1 day
Secondary	Fluid administration	ml/kg	1 day
Secondary	Number of participants with Vasopressor or Inotrope administered	Proportion	1 day
Secondary	Number of participants with erythrocyte administration	Proportion	1 day
Secondary	Fraction of inspired oxygen		1 day